MAUDE Adverse Event Report: SYNTHES GMBH PFNA 9 LONG R 130 L340 TAN ROD, FIXATION, INTRAMEDULLARY

Catalog Number 472.412S

Device Problem Break (1069)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a valgus malalignment and a not fully healed femur fracture were diagnosed through x-ray images. A revision surgery was performed on (b)(6) 2020 to correct the valgus malalignment. During the revision it was noticed that the proximal femoral nail antirotation (pfna) nail was broken. The pfna was revised. No further information provided. Concomitant devices reported: pfna blade perf l90 tan (part 04. 027. 033s, lot 50p9419, quantity 1); lockscr ø5 l36 f/nails tan light green (part 04. 005. 526s, lot 5l66048, quantity 1); lockscr ø5 l38 f/nails tan light green (part 04. 005. 528s, lot 6l89022, quantity 1). This report is for one (1) pfna ø9 long r 130° l340 tan. This is report 3 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. H3, h6: part: 472. 412s, lot: l798145, manufacturing site: bettlach, release to warehouse date: 15 march 2018, expiry date: 01. March 2028. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. Visual inspection: the received pfna nail is broken into two pieces at the distal guiding hole. Otherwise no other significant damages were found besides of slight scratches. All features related to the reported complaint condition were reviewed and no other issues were identified. Dimensional inspection: the outer and inner diameter of the shaft (near to breakage point) was measured and found to meet the specifications. Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition. Furthermore, as indicated in the manufacturing documents, the correct material titanium alloy (tial6nb7) was used according iso 5832-11. The broken surface is homogenous what indicates material conformity as well. Summary: the complaint condition is confirmed as the nail was found broken. The for the complaint relevant dimensions were checked as far as possible and found to be within specifications. These findings let us exclude a manufacturing related issue. Based on the provided information we assume that during the healing process, e. G. Non-union, delayed union, mal-union, overloading of the osteosynthesis or a combination of different factors, did lead to a fatigue failure. During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFNA 9 LONG R 130 L340 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10868377
• Report Number: 8030965-2020-09061
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819295216
• UDI-Public: (01)07611819295216
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 472.412S
• Device Lot Number: L798145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/23/2020

Is This a Reprocessed and Reused Single-Use Device?

• Patient Treatment(s): LOCKSCR Ø5 L36 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; PFNA BLADE PERF L90 TAN
• Patient Outcome(s): Required Intervention